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SAFETY OF INACTIVATED POLYMER-SUBUNIT THREE VALENCE INFLUENZA VACCINE. POSTREGISTRATIONAL OBSERVATION

Abstract

Clinical trial for polymer-subunit trivalent influenza vaccine Grippol plus reactogenicity assessment in 153 children aged 3–17 years old was conducted in the frames of post-registration studies. Prior to the vaccination the written informed agreement was signed by every participant’ parent. In post-vaccination period physical examination and thermometry was performed daily in post-immunization days 1–5, on days 21–28 and then on a monthly basis for 4 months. Study results demonstrated that Grippol plus possesses low reactogenicity and can be applied in pediatrics for immunization in accordance with National Immunization schedule.
Key words: children, influenza, vaccination.
(Voprosy sovremennoi pediatrii — Current Pediatrics. 2009;8(4):37-41)

About the Authors

S.M. Kharit
Scientific Institute of Children’s Infections, St. Petersburg
Russian Federation


E.P. Nacharova
Scientific Institute of Children’s Infections, St. Petersburg
Russian Federation


T.V. Chernyaeva
Scientific Institute of Children’s Infections, St. Petersburg
Russian Federation


References

1. CDC. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR. 2005; 54 (8):1–42.

2. Fiore A.E., Shay D.K., Broder K., Iskander J.K. et al. Prevention and Control of Influenza Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008; 57 (7): 1–60.

3. Пинегин Б.В., Иванова А.С., Климова С.В. и др. Влияние тривалентной конъюгированной полимерсубъединичной вакцины Гриппол® на иммунный статус привитых добровольцев, Иммунология. 2003; 3: 8–15.

4. Отчет клинических испытаний вакцины гриппозной тривалентной инактивированной полимерсубъединичной Гриппол® плюс (Фаза исследования: I, II). 05.03.2008.


Review

For citations:


Kharit S., Nacharova E., Chernyaeva T. SAFETY OF INACTIVATED POLYMER-SUBUNIT THREE VALENCE INFLUENZA VACCINE. POSTREGISTRATIONAL OBSERVATION. Current Pediatrics. 2009;8(4):37-41.

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ISSN 1682-5527 (Print)
ISSN 1682-5535 (Online)